10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
WEC-WASH, CATALOG NO. 850-115
FDA 510(k)
FDA Class 1
·General Hospital
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809640793·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...
PARTIAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HSX·April 20, 2023
MODIFICATION TO CD HORIZON SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Persona Partial Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
PARTIAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HSX·July 25, 2022
VIVA QUAD S
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code NIK·June 10, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 8, 2010
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 28, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012